Effect of a new oral contraceptive with drospirenone on vital signs, complete blood count, glucose, electrolytes, renal, and liver function.

ABSTRACT

OBJECTIVE: To evaluate the effect of a new oral contraception formulation with drospirenone (Yasmin) on vital signs, complete blood count, glucose, electrolytes, and renal and liver function. MATERIAL AND METHOD: An open-label non-comparative clinical trial was conducted. One hundred women who were planning to use oral contraception for at least six months were recruited. The subjects received a blister pack which contained 21 tablets of 3 mg drospirenone /30 tg ethinyl estradiol for the first four cycles (1 cycle = 28 days). Cycle 5 and 6 blister packs were dispensed during the visit in cycle 4. Heart rate and blood pressure of each subject were checked at baseline and each visit. Serum from each subject was collected and sent for complete blood count, glucose, electrolytes, and renal and liver function tests at baseline and at cycle 6. Mean differences in these tests at cycle 6 compared to baseline were assessed. RESULTS: Ninety-two of the 100 subjects (92%) completed the present study. There was no significant change in heart rate, blood pressure, complete blood count, glucose, electrolytes, and renal and liver function tests at cycle 6 when compared to baseline. CONCLUSION: Oral contraception formulation with drospirenone (Yasmin) is well tolerated and has good contraceptive efficacy. It is safe, as it has no effect on heart rate, blood pressure, complete blood count, glucose, electrolytes, and renal and liver function.